drugset / Trial / NCT05821751
The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors
Unknown
40 enrolled
Fondazione del Piemonte per l'Oncologia
Ospedale Santa Croce-Carle Cuneo · collabUniversità degli Studi di Trento · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The PRINCESS study is a hypothesis-generating, interventional, open-label, non pharmacological trial designed to characterize the translational and clinical implications of the regular assumptions of inulin on Gut Microbiota, circulating cytokines and immune cells dynamics during ICIs +/- chemotherapy on patients affected by R/M HNSCC.
Timeline
- Start
- 2021-12-02
- Primary completion
- 2024-12-02
- Completion
- 2025-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |